ICYMI: Highlights From ASCO GU 2025

The 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), held February 13-15, 2025, in San Francisco, California, showcased significant advancements in the treatment and understanding of genitourinary cancers, particularly focusing on prostate cancer, renal cell carcinoma (RCC), and critical issues surrounding health equity and research funding. Our coverage highlighted key trial data, discussions on optimizing patient care, and efforts to address systemic barriers in oncology research.

Here is the top ASCO GU coverage.

5. Getting More Doctors to Record a Life-Saving Prostate Cancer Calculation

A major theme emerging from the symposium centered on improving standardized monitoring tools for prostate cancer, particularly prostate-specific antigen doubling time (PSADT). PSADT measures how quickly PSA levels increase and is considered a critical predictor of outcomes for patients treated for prostate cancer, guiding decisions like whether to initiate salvage androgen deprivation therapy. However, research presented by Alicia Morgans, MD, MPH, highlighted that physicians frequently estimate PSADT rather than fully calculating it, or they fail to record it consistently in their notes, often due to the effort and time required to manually perform the calculation.

This lack of standardized, accurate documentation leads to potentially missed treatment opportunities for high-risk patients. For instance, a study review of patients with high-risk biochemical recurrence found that those with unknown PSADT had rapidly doubling PSA more frequently (61% vs 20%) yet experienced delayed treatment (median time to treatment, 6.7 months vs 1.0 month for those with known PSADT). Moreover, when doctors overestimate the doubling time, they underestimate the aggressiveness of the cancer and the risk of metastasis, which can lead to delayed or inappropriate treatment and subsequent complications. Experts suggested that integrating standardized PSADT calculation directly into electronic health records could drastically improve accuracy, ensure regulatory compliance for high-risk drug approvals, and optimize treatment timing, potentially saving patients from metastasis and expensive interventions.

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4. Phase 1 Study Identifies Casdatifan Dose With Promising Responses in Pretreated Clear Cell RCC

Promising early-stage data were presented for casdatifan, a novel HIF-2α inhibitor for clear cell RCC (ccRCC), the most common type of kidney cancer. Results from the phase 1 ARC-20 trial (NCT05536141) showed that the 100-mg/day dose of casdatifan yielded clinically meaningful objective responses in 33% of patients who had been previously treated with PD-1 inhibitors and vascular endothelial growth factor receptor–tyrosine kinase inhibitor therapy. Casdatifan works by targeting hypoxia-inducible factor 2⍺, a transcription factor that, when unchecked, enables genes that promote tumor growth by switching off the body's anti-inflammatory responses.

The 100-mg once-daily dose was identified as the appropriate dosage to move forward into combination strategies and a phase 3 trial. While adverse events (TEAEs) were noted, including common events like anemia (seen in 79% to 90% across all doses), the TEAE rate of grade 3 or higher was lowest in the 100 mg/day group (41%). A subsequent phase 3 study, PEAK-1 (NCT07011719), is planned to combine the 100-mg daily dose of casdatifan with cabozantinib (Cabometyx; Exelixis) for patients with advanced ccRCC who have previously received an immune checkpoint inhibitor.

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3. TALAPRO-2 Overall Survival Data Suggest New Standard of Care in mCRPC, Regardless of Genomic Status

Final overall survival (OS) data from the phase 3 TALAPRO-2 trial (NCT03395197) suggests that the combination of talazoparib (Talzenna; Pfizer), a poly ADP-ribose polymerase (PARP) inhibitor, and enzalutamide (Xtandi; Astellas Pharma/Pfizer), an androgen receptor pathway inhibitor, could become the new standard of care for patients with metastatic castration-resistant prostate cancer (mCRPC), regardless of their homologous recombination repair (HRR) genomic status.

In the unselected cohort (cohort 1), which included patients regardless of genomic status, the combination reduced the risk of death by 20.4%. After 52.5 months of follow-up, the median OS for the combination group was 45.8 months compared with 37.0 months for enzalutamide plus placebo. This trial is significant, as it provides the first meaningful survival benefit from the combination of these 2 drug classes in prostate cancer. Critically, experts noted that the combination demonstrated synergy against cancer without resulting in increased toxicity; the adverse effect profile was "essentially exactly the same" as using either drug alone, which is a major benefit given the duration of treatment. Cohort 2, focusing on patients with known HRR alterations, showed a 38% reduction in the risk of death, with a median OS of 45.1 months in the combination group vs 31.1 months in the enzalutamide-only group. Pfizer, the maker of the drugs, looks forward to label updates to reflect these positive OS data, which highlight the combination’s potential as a practice-changing treatment to improve patient survival in mCRPC.

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2. ACS’ Dahut on Finding Cancer Before It Starts, and Funding Researchers as They Start

William Dahut, MD, the chief scientific officer for the American Cancer Society (ACS), delivered a keynote address outlining the organization's mission pillars: promoting discovery, engaging in advocacy, and providing patient support. Dahut highlighted the ACS's commitment to funding research, including smaller awards crucial for early-career investigators to gain a foothold in the competitive funding pipeline. The ACS has an "incredible passion for funding the next generation of scientists" to create equal opportunity across the board.

The 4 core pillars of the ACS’s discovery mission are accelerating the understanding of cancer mechanisms, improving patient and survivorship outcomes, decreasing suffering through research into screening and early detection, and investing in the next generation of scientists. The ACS currently funds 870 grants across 216 institutions, including 941 investigators. Dahut noted the concerning trend of increased cancer rates among younger adults and the low screening rates for prostate cancer since COVID-19. The ACS is increasing its focus on genitourinary cancers, particularly prostate cancer, by funding IMPACT awards aimed at reducing the burden of the disease, especially in high-risk populations such as Black men. A critical goal of this focus is to address the broader issue of equitable access in clinical trials. Dahut also expressed hope for the use of artificial intelligence in augmenting staff for areas like pathology, which can help detect the earliest cancers.

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1. “Expanding Access Isn’t Just About Fairness—It’s About Building Better Treatments for Everyone”

An insightful presentation at ASCO GU by Regina Barragan-Carrillo, MD, underscored the global inequities in clinical trials for RCC and the broad implications for medical knowledge. Her findings revealed that 76% of RCC trials are conducted exclusively in high-income countries, with none available in low-income countries. This geographic disparity is particularly troubling because lower socioeconomic status is strongly linked to a higher risk of developing RCC and worse survival outcomes globally, with 5-year survival rates up to 50% lower in poorer countries.

Barragan-Carrillo stressed that this lack of diversity is not just an ethical issue of fairness but a scientific barrier. By limiting trials to wealthy countries, researchers miss critical information about how treatments perform in the real world, particularly concerning drug delivery, quality assurance, and efficacy in populations dealing with coexisting conditions, such as malnutrition or parasitic infection, that are more common in low-income regions. Expanding global trial access provides scientific benefits by incorporating greater genetic diversity, which is crucial for understanding pharmacodynamics and pharmacokinetics and developing more effective, universally applicable treatments. It also presents the opportunity for "reverse engineering," where treatments are adapted in lower-income settings and then brought back to higher-income settings to be more cost-effective, thus reducing financial toxicity for patients worldwide. Current funding cuts to global health research actively worsen these inequities by shrinking opportunities and hindering the necessary international collaborations needed to improve outcomes for the majority of the world's patients with cancer.

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